FDA 510(k)

VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)

K-Number: K973030 · 1997-09-04

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.

Decision Date1997-09-04

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K973030. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)?

VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K973030.

When did VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) received FDA 510(k) clearance on 1997-09-04, under 510(k) number K973030.

Who is the listed applicant for VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)?

The FDA 510(k) record lists Johnson & Johnson Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)?

The FDA product code for VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) is JJY.

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Other records listing Johnson & Johnson Clinical Diagnostics, Inc. as applicant

K980283VITROS CHEMISTRY PRODUCTS CRBM SLIDES K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)K970894VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.